MAUDE Adverse Event Report: ARTHREX, INC. TENO SCRW,BIO-COMP; SCREW, FIXATION, BONE

Model Number	TENO SCRW,BIO-COMP
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during arthroscopy when the screw was tightened the screw crumbled.All pieces were retrieved from patient.No harm for patient, operator or third party was reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
- it was reported that the screw broke.- the reported event is confirmed upon investigation of the returned picture.- visual evaluation identified that the screw had broken into several pieces.Surgical technique and preparation or patient bone quality was not noted for this complaint.Additionally, without the return of the device, further investigation cannot be performed.- the root cause of the reported failure mode is undetermined.However, the most likely probable cause is applying excessive mechanical forces upon insertion.

• Brand Name: TENO SCRW,BIO-COMP
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11475437
• Report Number: 1220246-2021-02717
• Device Sequence Number: 11504608
• Product Code: HWC
• UDI-Device Identifier: 00888867018778
• UDI-Public: 00888867018778
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: TENO SCRW,BIO-COMP
• Device Catalogue Number: AR-1547BC
• Device Lot Number: 10977782
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/12/2021
• Supplement Report FDA Received Date: 09/07/2021
• Patient Sequence Number: 1